AZOLEN- miconazole nitrate liquid

AZOLEN by

Drug Labeling and Warnings

AZOLEN by is a Otc medication manufactured, distributed, or labeled by STRATUS PHARMACEUTICALS INC, TARMAC PRODUCTS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Miconazole Nitrate 2%

Purpose

Topical Antifungal

Uses

• For the treatment of most:
  • athlete's foot
  • jock itch
  • ringworm
• Relieves:
  • itching
  • scaling
  • cracking
  • burning
  • redness
  • discomfort

Warnings

for external use only

Do not use

• on children under 2 years of age unless directed by a doctor
• for diaper rash

When using this product

• avoid contact with eyes

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 2 weeks (for jock itch)
• there is no improvement within 4 weeks (for athlete's foot and ringworm)

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately

Directions

• Wash the affected area well with AZOLEN Anti-Fungal Wash and let product sit 1-2 minutes before rinsing
• Dry the affected area thoroughly
• Apply the product over the affected area twice daily (morning and night) or as directed by a doctor
• Supervise children in the use of this product
• For athlete's foot: Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
• For athlete's foot and ringworm, use daily for 4 weeks
• For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor
• This product is not effective on scalp or nails

Other Information

• Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) [See USP Controlled Room Temperature]

Inactive Ingredients

Lauramidopropyl Betaine, Laureth-7, Panthenol, Phospholipid EFA, Purified Water, Sodium Chloride, Sodium C14-16 Olefin Sulfonate, Tea Tree Oil.

Questions or Comments?

Call us at 1-800-442-7882

SPL UNCLASSIFIED SECTION

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186

PRINCIPAL DISPLAY PANEL - 170 g Bottle Box

NDC: 58980-819-60

AZOLEN™
ANTI-FUNGAL WASH

(MICONAZOLE NITRATE 2%)

NOW TREAT
JOCK ITCH IN
THE SHOWER

SOOTHES AND
CONTROLS MOST:*
JOCK ITCH
ATHLETE'S FOOT
RINGWORM

STRATUS
PHARMACEUTICALS INC

Net Wt 6 oz (170 g)

INGREDIENTS AND APPEARANCE

AZOLEN 
miconazole nitrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58980-819
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PANTHENOL (UNII: WV9CM0O67Z)
TEA TREE OIL (UNII: VIF565UC2G)
LAURETH-7 (UNII: Z95S6G8201)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)
LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58980-819-60	1 in 1 BOX	09/14/2023
1		170 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	09/14/2023

Labeler - STRATUS PHARMACEUTICALS INC (789001641)

Establishment
Name	Address	ID/FEI	Business Operations
TARMAC PRODUCTS INC		059890491	MANUFACTURE(58980-819)